추천 제품
제조업체/상표
Millipak®
Quality Level
Matrix
Durapore®
공극 크기
0.45 μm
버블 포인트(bubble point)
≥1790 mbar (26 psig), air with water at 23 °C
피팅
inlet sanitary flange
outlet sanitary flange
(19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)
일반 설명
Device Configuration: Gamma Gold Capsule
Number of stacked discs: 20 discs
포장
Blister
기타 정보
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use
- Organism Retention: Microorganism
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer Wetting Instructions for Filter Units with Durapore® Membrane user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
제조 메모
Sterilization Method
3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable
3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
분석 메모
Gravimetric Extractables: using sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
법적 정보
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany
시험 성적서(COA)
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